Table 1.
Demographic and clinical characteristics at baseline
| ACHIEVE trials (N = 2247)a | LTS trial (N = 813)b | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo POOLED | Ubrogepant 50 mg POOLED |
Ubrogepant 100 mg ACHIEVE I |
Ubrogepant 50 mg and 100 mg POOLED | |||||
| With preventive (n = 180) | Without preventive (n = 732) | With preventive (n = 164) | Without preventive (n = 723) | With preventive (n = 73) | Without preventive (n = 375) | With preventive (n = 143) | Without preventive (n = 670) | |
| Age, mean (SD), years | 43.5 (11.4) | 40.5 (12.0) | 42.8 (11.2) | 39.9 (12.2) | 43.7 (12.2) | 39.7 (12.0) | 44.7 (11.2) | 41.3 (11.8) |
| Sex, female, n (%) | 160 (88.9) | 649 (88.7) | 153 (93.3) | 650 (89.9) | 67 (91.8) | 319 (85.1) | 133 (93.0) | 606 (90.4) |
| Race, n (%) | ||||||||
| White | 163 (90.6) | 591 (80.7) | 146 (89.0) | 582 (80.5) | 68 (93.2) | 304 (81.1) | 127 (88.8) | 560 (83.6) |
| Black/African American | 13 (7.2) | 113 (15.4) | 16 (9.8) | 119 (16.5) | 5 (6.8) | 58 (15.5) | 14 (9.8) | 92 (13.7) |
| Ethnicity, n (%) | ||||||||
| Hispanic or Latinx | 9 (5.0) | 123 (16.8) | 13 (7.9) | 133 (18.4) | 3 (4.1) | 43 (11.5) | 9 (6.3) | 111 (16.6) |
| BMI, mean (SD), kg/m2 | 29.4 (7.3) | 30.0 (7.7) | 29.6 (7.8) | 30.5 (7.8) | 27.3 (6.3) | 31.2 (8.2) | 28.6 (7.7) | 30.0 (7.6) |
| Duration of migraine, mean (SD), years | 21.6 (13.0) | 18.5 (12.3) | 20.2 (12.2) | 17.4 (12.0) | 20.1 (12.5) | 18.7 (12.2) | 21.0 (12.7) | 18.4 (11.4) |
| Frequency of moderate/severe headaches in previous 3 months, n (%) | ||||||||
| 2–4 attacks/month | 94 (52.2) | 432 (59.0) | 80 (48.8) | 425 (58.8) | 34 (46.6) | 211 (56.3) | 66 (46.2) | 405 (60.4) |
| 5–8 attacks/month | 86 (47.8) | 300 (41.0) | 84 (51.2) | 298 (41.2) | 39 (53.4) | 164 (43.7) | 77 (53.8%) | 265 (39.6) |
| Preventive medications, n (%) | ||||||||
| Anticonvulsants | 91 (50.5) | 0 | 85 (51.8) | 0 | 32 (43.8) | 0 | 71 (49.7) | 0 |
| Beta blockers | 28 (15.6) | 0 | 27 (16.5) | 0 | 15 (20.5) | 0 | 26 (18.2) | 0 |
| Antidepressants | 37 (20.6) | 0 | 43 (26.2) | 0 | 13 (17.8) | 0 | 35 (24.5) | 0 |
| OnabotulinumtoxinA | 57 (31.7) | 0 | 36 (22.0) | 0 | 21 (28.8) | 0 | 42 (29.4) | 0 |
BMI body mass index, LTS long-term safety, SD standard deviation
aModified intent-to-treat population. Data from the ubrogepant 25 mg group were not included in this analysis
bSafety population. Because of the small subgroup sample sizes, data from both ubrogepant treatment arms (50 mg and 100 mg) were combined for this analysis